Job Description

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

Summary:

As an essential leader within the Quality Assurance & Regulatory Compliance organization, the Sr. Manager/ Associate Director of Nonconformance & CAPA Management provides enterprise-level ownership, strategic leadership, and program governance over the company’s Nonconformance (NC), Corrective and Preventive Action (CAPA), Planned Deviation (PD), and Quality Investigation systems.

This role serves as the authoritative subject matter expert (SME) ensuring strict compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485:2016, CLIA/CAP, and applicable global in vitro diagnostic (IVD) regulatory requirements. The incumbent is responsible for driving organizational maturity from reactive compliance to proactive, data-driven prevention, presenting critical health-of-quality metrics to executive leadership, and championing continuous process improvement across Clinical Laboratory Operations, Assay Development, and Manufacturing/Supply Chain. This position reports to the Sr. Director of Quality Assurance.

Hybrid: Monday and Tuesday onsite, plus additional days as needed

Responsibilities:

• Strategic Program Oversight & Governance
• Management Reporting & Executive Communication
• Establish key performance indicators (KPIs) and operational SLAs for the NC/CAPA lifecycle (e.g., cycle times, aging rates, reoccurrence rates, root-cause categorization, effectiveness success rates) to proactively identify systemic risk trends.
• Communicate quality risks, resource bottlenecks, and compliance vulnerabilities transparently to the Senior Director of Quality and operational business unit heads.
• Continuous Process Improvement & Operational Excellence
• Regulatory Compliance & Audit Readiness (21 CFR Part 820 Focus)
• Other responsibilities assigned by Leadership.

Experience & Technical Skills:

• Experience Level: Minimum of 8 - 10+ years of progressive Quality Assurance / Quality Systems experience in an FDA-regulated in vitro diagnostic (IVD), medical device, and / or clinical laboratory environment, with at least 4+ years in a formal program management or supervisory/leadership capacity.
• Regulatory Proficiency: Solid command of 21 CFR Part 820, ISO 13485:2016, and ISO 14971; working familiarity with CLIA '88, CAP, NYS CLEP, and IVDR (EU 2017/746) is highly preferred.
• eQMS Leadership: Demonstrated track record configuring, optimizing, and administrating enterprise eQMS platforms (e.g., ComplianceQuest, Veeva Vault, MasterControl, TrackWise, or Qualio).
• Inspection Defense: Proven success defending CAPA, Deviation, and Nonconformance files directly in front of FDA investigators and ISO/Notified Body auditors.
• Executive Presence: Exceptional communication, data visualization, and technical writing skills, with the ability to influence cross-functional leaders without direct authority.
• Excellent ability to manage multiple priorities and meet agreed-upon timelines.

The hiring range for this position is $165,000 to $210,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.

Protecting Our Candidates: At Personalis, we value your security. Please note that all official correspondence from our team will come exclusively from @personalis.com email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.

Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package and benefits including medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.)

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